Regulatory approval

Published by the Health Canada.

Health Canada approved niraparib and abiraterone acetate in combination with prednisone or prednisolone for the treatment of adult patients with deleterious or suspected deleterious BRCA-mutated (germline and/or somatic) metastatic castration-resistant prostate cancer (mCRPC), who are asymptomatic or mildly symptomatic, and in whom chemotherapy is not clinically indicated.

This is written in the approval document as:

AKEEGA (niraparib and abiraterone acetate) is indicated with prednisone or prednisolone for the treatment of adult patients with deleterious or suspected deleterious BRCA mutated (germline and/or somatic) metastatic castration resistant prostate cancer (mCRPC), who are asymptomatic/mildly symptomatic, and in whom chemotherapy is not clinically indicated.

Citation

Janssen Inc. Akeega (abiraterone acetate and niraparib) [product monograph]. Health Canada website. https://pdf.hres.ca/dpd_pm/00078864.PDF. Revised March 2025. Accessed June 2025.

Therapeutic response

Precision oncology relationships for therapeutic response derived from this regulatory approval.

Organization(s)	Biomarker(s)	Cancer type	Therapy(ies)
HC (1)	BRCA1 oncogenic variants	Prostate Adenocarcinoma	Abiraterone acetate, Niraparib, Prednisone
HC (1)	BRCA1 pathogenic variants	Prostate Adenocarcinoma	Abiraterone acetate, Niraparib, Prednisone
HC (1)	BRCA2 oncogenic variants	Prostate Adenocarcinoma	Abiraterone acetate, Niraparib, Prednisone
HC (1)	BRCA2 pathogenic variants	Prostate Adenocarcinoma	Abiraterone acetate, Niraparib, Prednisone
HC (1)	BRCA1 oncogenic variants	Prostate Adenocarcinoma	Abiraterone acetate, Niraparib, Prednisolone
HC (1)	BRCA2 oncogenic variants	Prostate Adenocarcinoma	Abiraterone acetate, Niraparib, Prednisolone
HC (1)	BRCA1 pathogenic variants	Prostate Adenocarcinoma	Abiraterone acetate, Niraparib, Prednisolone
HC (1)	BRCA2 pathogenic variants	Prostate Adenocarcinoma	Abiraterone acetate, Niraparib, Prednisolone